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Device | THERAPY DUAL 8 CARDIAC ABLATION SYSTEM,THERAM 8MM THERMISTER ABLATION CATHETER SAFIRE TX ABLATION CATHETER |
Generic Name | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter |
Applicant | IRVINE BIOMEDICAL,INC.(IBI) 2375 MORSE AVE. IRVINE, CA 92614 |
PMA Number | P040042 |
Date Received | 10/04/2004 |
Decision Date | 11/18/2005 |
Product Code |
OAD |
Docket Number | 05M-0476 |
Notice Date | 11/28/2005 |
Advisory Committee |
Cardiovascular |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE THERAPY DUAL 8 CARDIAC ABLATION SYSTEM. THE DEVICE IS INDICATED FOR THE TREATMENT OF TYPICAL ATRIAL FLUTTER. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 S036 S037 S040 S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S051 S052 S053 S054 S055 |